I knew that you’d come back to learn about more temperature applications within the life science industry!  Today we are discussing a slightly warm, maybe uncomfortably warm temperature, 32°C!  This temperature is important in quality control testing and manufacturing of biological drug products.

One example is in biologic facilities, where the manufacture of drug products could start with cells that are grown in bioreactors or incubator shakers with perfect temperature conditions of 32°C.  The perfect warm temperature also depends on the procedures, processes, and types of cells involved and does not have to be set in stone at 32°C.  Incubator shakers combine constant movement and warm temperature for inoculating and growing cells in media for manufacturing.  These cells are then moved to larger bioreactors in order to further grow and proliferate.  Bioreactors are kept at warm, moist temperatures, depending on the cell line or product, in order keep all the cells happy and stable.

During the entire manufacturing process quality checks need to be implemented to make sure nothing has been comprimised.  This is where Quality Control comes into play and confirms sterility and other quality aspects with the help of incubators or water baths.  Incubators provide a perfect, stable, and warm environment for placement of agar plates for testing of sterility and growth of certain harmful or unwanted bacterium.

Incubators, water baths, and bioreactors need to be validated and monitored for temperature fluctuations.  Once validation of the units has been completed, a monitoring system should be implemented to continuously monitor your crucial temperature values in real time for your critical manufacturing and quality control processes in a FDA compliant environment.

Tune in next week for our discussion about +121°C temperatures, or sterilization of your processes and products.